InTake Care: Personalized voice-assistant support to help people stick with blood pressure medicines
InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
This trial will test whether a voice assistant plus a doctor-facing web app can help adults with high blood pressure take their blood-pressure medicines more regularly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06229171 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial uses a low-cost digital adherence system built on a commercial voice assistant linked to a physician web interface to support patients on chronic antihypertensive therapy. The intervention will be personalized through multidisciplinary 'Personas' that tailor reminders and interactions to different user types. Participants will be randomized to receive the personalized voice-assistant support or usual care, with adherence tracked by device logs and dedicated plasma assays for at least one antihypertensive drug. The project is run by Istituto Auxologico Italiano with technical and clinical collaborators from Politecnico di Milano and Istituti Clinici Scientifici Maugeri.
Who should consider this trial
Good fit: Adults over 18 with essential hypertension who take at least one antihypertensive drug measurable in plasma, have a home wireless internet connection, stable clinical status, can use an Italian-language voice assistant, and can give written informed consent.
Not a fit: Patients unlikely to receive benefit include those with dementia or major psychiatric disorders, insufficient technological literacy, significant speech or hearing impairments, poor Italian language skills, lack of home internet, pregnancy or active cancer, or upper limb amputation.
Why it matters
Potential benefit: If successful, this approach could improve medication adherence using inexpensive, widely available technology and thereby help reduce cardiovascular risk.
How similar studies have performed: Some digital and voice-based adherence tools have produced modest improvements in medication-taking, but a fully personalized voice-assistant system combined with biochemical adherence verification is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years old) patients * History of essential hypertension * Treatment with at least one antihypertensive drug for which dedicated plasma essay is available * wireless internet connection available at patients' home * stable clinical conditions * written informed consent Exclusion Criteria: * insufficient technological literacy to manage vocal assistant * dementia or significant psychiatric disorders * conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian language) * pregnancy or breastfeeding * active cancer (except basal cell skin carcinoma) * upper limb amputation
Where this trial is running
Milan
- San Luca Hospital, Istituto Auxologico Italiano IRCCS — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Grzegorz Bilo, MD, PhD — Istituto Auxologico Italiano
- Study coordinator: Grzegorz Bilo, MD, PhD
- Email: g.bilo@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.